GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)
Primary Purpose
COVID-19, Healthy
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GLS-5310 (Group 1)
GLS-5310 (Group 2)
GLS-5310 (Group 3)
GLS-5310 (Group 4)
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Vaccine, DNA
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 65 years of age
- Able to provide informed consent
- Able and willing to comply with study procedures and agree to refrain from obtaining a booster vaccination with a non-study vaccine through to the 1 month post-boost vaccination visit
- For women of childbearing potential, able and willing to use an approved form of pregnancy prevention for at least 4 weeks from study drug administration
- Completion of a prior vaccination series with either the BNT162b2, mRNA-1273, or Ad26.CoV.S vaccines, with or without subsequent booster vaccination, with most recent vaccination at least 6 months prior to study entry
Exclusion Criteria:
- Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection (https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html)
- Persons with a diagnosis of type 2 diabetes mellitus
- Persons with a diagnosis of chronic kidney disease
- Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)
- Persons with a diagnosis of heart conditions to include heart failure, coronary artery disease, prior heart attack, cardiomyopathy
- Sickle cell disease
- Current or planned pregnancy during the study
- Currently breastfeeding
- Administration of an investigational agent within 90 days of the GLS-5310 booster dose
- Administration of a vaccine within 2 weeks prior to the GLS-5310 booster dose
- Administration of immune globulin within 6 months of enrollment
- Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 6 months from enrollment
- Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater; or the equivalent dose of other systemic corticosteroids
- Treatment within the four weeks prior to enrollment with any drug intended for the prophylaxis or treatment of COVID-19
- Any prior treatment with an anti-SARS-CoV-2 monoclonal antibody or immune serum
- Prior treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix B exclusionary period for specific drugs)
- History of malignancy
- History of transplantation (any organ or bone marrow)
- Current or planned chemotherapy treatment for hematologic or solid tumor during study period
- History of other congenital or acquired immunodeficiency, excluding those with HIV infection who are taking highly active antiretroviral therapy and who have documentation of undetectable serum viral load and who have a CD4 count > 200 cells/μL on two measures at least 3 months apart
- Not willing to allow storage and future use of samples for coronavirus-related research and/or vaccine development
- Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
- Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint
- History of chronic rhinosinusitis
- History of nasal septal defect or deviated nasal septum
- History of cleft palate
- History of nasal polyps
- History of other disorders that, in the opinion of the investigator, may adversely affect administration of intranasal vaccine
Sites / Locations
- Meridian Clinical Research
- Meridian Clinical Research
- Clinical Research Puerto Rico
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
GLS-5310 ID + GeneDerm 65 kPa, 30 seconds
GLS-5310 ID + GeneDerm 65 kPa, 30 seconds + GLS-5310 IN
GLS-5310 ID + GeneDerm 65 kPa, 15 seconds
GLS-5310 ID + GeneDerm 80 kPa, 30 seconds
Arm Description
GLS-5310 ID + GeneDerm administered at Visit 1
GLS-5310 ID + GeneDerm + GLS-5310 IN administered at Visit 1
GLS-5310 ID + GeneDerm administered at Visit 1
GLS-5310 ID + GeneDerm administered at Visit 1
Outcomes
Primary Outcome Measures
Incidence of adverse events
Solicited/unsolicited local and systemic AEs after vaccination
Determine antibody responses after a single dose of vaccine
The fold change of SARS-CoV-2 Spike binding antibodies 1-month post-booster
Secondary Outcome Measures
Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine
Evaluation of neutralizing antibody response induced by GLS-5310 relative to treatment arm
Full Information
NCT ID
NCT05182567
First Posted
January 5, 2022
Last Updated
September 11, 2023
Sponsor
GeneOne Life Science, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05182567
Brief Title
GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)
Official Title
Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Given as a Booster to Those Previously Vaccinated Against SARS-CoV-2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeneOne Life Science, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase I study to assess the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine given as a booster to those previously vaccinated against SARS-CoV-2
Detailed Description
This Phase I, randomized, placebo-controlled study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration given as a heterologous booster dose to those previously vaccinated against SARS-CoV-2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Healthy
Keywords
Vaccine, DNA
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GLS-5310 ID + GeneDerm 65 kPa, 30 seconds
Arm Type
Experimental
Arm Description
GLS-5310 ID + GeneDerm administered at Visit 1
Arm Title
GLS-5310 ID + GeneDerm 65 kPa, 30 seconds + GLS-5310 IN
Arm Type
Experimental
Arm Description
GLS-5310 ID + GeneDerm + GLS-5310 IN administered at Visit 1
Arm Title
GLS-5310 ID + GeneDerm 65 kPa, 15 seconds
Arm Type
Experimental
Arm Description
GLS-5310 ID + GeneDerm administered at Visit 1
Arm Title
GLS-5310 ID + GeneDerm 80 kPa, 30 seconds
Arm Type
Experimental
Arm Description
GLS-5310 ID + GeneDerm administered at Visit 1
Intervention Type
Drug
Intervention Name(s)
GLS-5310 (Group 1)
Intervention Description
GLS-5310 DNA plasmid vaccine
Intervention Type
Drug
Intervention Name(s)
GLS-5310 (Group 2)
Intervention Description
GLS-5310 DNA plasmid vaccine
Intervention Type
Drug
Intervention Name(s)
GLS-5310 (Group 3)
Intervention Description
GLS-5310 DNA plasmid vaccine
Intervention Type
Drug
Intervention Name(s)
GLS-5310 (Group 4)
Intervention Description
GLS-5310 DNA plasmid vaccine
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Solicited/unsolicited local and systemic AEs after vaccination
Time Frame
Through 48 weeks post vaccination
Title
Determine antibody responses after a single dose of vaccine
Description
The fold change of SARS-CoV-2 Spike binding antibodies 1-month post-booster
Time Frame
Through 48 weeks post vaccination
Secondary Outcome Measure Information:
Title
Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine
Time Frame
Through 48 weeks post vaccination
Title
Evaluation of neutralizing antibody response induced by GLS-5310 relative to treatment arm
Time Frame
Through 48 weeks post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 65 years of age
Able to provide informed consent
Able and willing to comply with study procedures and agree to refrain from obtaining a booster vaccination with a non-study vaccine through to the 1 month post-boost vaccination visit
For women of childbearing potential, able and willing to use an approved form of pregnancy prevention for at least 4 weeks from study drug administration
Completion of a prior vaccination series with either the BNT162b2, mRNA-1273, or Ad26.CoV.S vaccines, with or without subsequent booster vaccination, with most recent vaccination at least 6 months prior to study entry
Exclusion Criteria:
Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection (https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html)
Persons with a diagnosis of type 2 diabetes mellitus
Persons with a diagnosis of chronic kidney disease
Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)
Persons with a diagnosis of heart conditions to include heart failure, coronary artery disease, prior heart attack, cardiomyopathy
Sickle cell disease
Current or planned pregnancy during the study
Currently breastfeeding
Administration of an investigational agent within 90 days of the GLS-5310 booster dose
Administration of a vaccine within 2 weeks prior to the GLS-5310 booster dose
Administration of immune globulin within 6 months of enrollment
Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 6 months from enrollment
Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater; or the equivalent dose of other systemic corticosteroids
Treatment within the four weeks prior to enrollment with any drug intended for the prophylaxis or treatment of COVID-19
Any prior treatment with an anti-SARS-CoV-2 monoclonal antibody or immune serum
Prior treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix B exclusionary period for specific drugs)
History of malignancy
History of transplantation (any organ or bone marrow)
Current or planned chemotherapy treatment for hematologic or solid tumor during study period
History of other congenital or acquired immunodeficiency, excluding those with HIV infection who are taking highly active antiretroviral therapy and who have documentation of undetectable serum viral load and who have a CD4 count > 200 cells/μL on two measures at least 3 months apart
Not willing to allow storage and future use of samples for coronavirus-related research and/or vaccine development
Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint
History of chronic rhinosinusitis
History of nasal septal defect or deviated nasal septum
History of cleft palate
History of nasal polyps
History of other disorders that, in the opinion of the investigator, may adversely affect administration of intranasal vaccine
Facility Information:
Facility Name
Meridian Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Meridian Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)
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